RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention

The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.

Trial Details

NCT ID
NCT06553235
Phase
NA
Sponsor
Aarhus University Hospital
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • Sleep hygiene education
Locations (sample)
  • Aarhus N, Denmark|56.20367,10.17317

Key Eligibility Criteria

  • Age ≥18 years
  • Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed)
  • Insomnia: a score of \>10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (…
  • Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organ…

For full eligibility, visit ClinicalTrials.gov.

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